Topical Paromomycin for Cutaneous Leishmaniasis in Bolivia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-15

Study Completion Date

2018-04-01

Brief Summary

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This protocol will compare topical paromomycin to standard intralesional (IL) antimony (Sb) to placebo for L braziliensis in Bolivia.

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Detailed Description

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Patients will be randomized between Paromomycin cream applied topically once daily for 20 days (group 1--40 patients), pentamidine administered intralesionally at 120 ug/mm2 on days 1, 3, 5 (group 2-20 patients), and cream vehicle applied topically once daily for 20 days (group 3-20 patients).

After treatment, all patients will be followed for 1, 3, and 6 months.

Conditions

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Leishmaniasis, Cutaneous Leishmania Braziliensis Complex Leishmaniasis, American Leishmaniasis; American, Cutaneous

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Patients will be randomized between Paromomycin cream applied topically once daily for 20 days (group 1--40 patients), pentamidine administered intralesionally at 120 ug/mm2 on days 1, 3, 5 (group 2-20 patients), and cream vehicle applied topically once daily for 20 days (group 3-20 patients).

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Group 1 (Paromomycin cream) will be compared to Group 3 (Vehicle cream). Both creams will have very similar physical characteristics and package. Group 2 (intralesional injection of pentamidine) will not be masked.

Study Groups

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Group 1 - Paromomycin cream

40 subjects will be included to receive 15% paromomycin in aquafilm base twice a day during 20 consecutive days. The lesion will be cleaned , then, a generous amount of the study drug (an amount sufficient to cover the area of the ulcer and the lesion border) will be applied to the lesion and rubbed into the ulcer using a gloved finger by a member of the clinical study staff. After application of the study drug, the patient will be observed for 15 minutes for signs of adverse events. If there are no signs of local toxicity, the area of the ulcer will be covered with extra study drug. For Days 2-20, the study drug will be applied and the lesion covered with a sterile gauze and tape dressing as on Day 1.

Group Type EXPERIMENTAL

Paromomycin Sulfate

Intervention Type DRUG

topical application 2 times a day during 20 days

Group 2. Local Injectable Pentamidine

20 subjects will be included to receive IL pentamidine \[Pentacarinat® Sanofi-Aventis: 30 mg/ml\] will administered at a dose of 120 ug (4 ul) per mm2 of lesion area 3 times (on days 1, 3, and 5) as per our previous experience.

A small button of Xylocaine® will be applied by means of a thin needle at the four cardinal points of the lesion and then a small gauge (23g) needle will introduce the drug in each cardinal point. The needle will be moved in all directions to infiltrate of whole lesion and surrounding infiltrated area.

Group Type ACTIVE_COMPARATOR

Pentamidine Isethionate

Intervention Type DRUG

3 Intralesional injections at days 1,3 and 5

Group 3. Vehicle control

10% Urea en parafilm cream will be used in similar ways as paromomycin cream in group 1

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

topical application 2 times a day during 20 days

Interventions

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Paromomycin Sulfate

topical application 2 times a day during 20 days

Intervention Type DRUG

Pentamidine Isethionate

3 Intralesional injections at days 1,3 and 5

Intervention Type DRUG

Placebo

topical application 2 times a day during 20 days

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Gender: Male or female
* Age: \>12 yrs of age
* Presentation: 1-to-2 ulcerative lesions, each \< 30 mm in largest diameter and with a total lesion area \<900 mm2.
* Parasitology: Parasitological confirmation of the lesion will be made by visualization or culture of Leishmania from the biopsy or aspirate of the lesion.

Exclusion Criteria

* Previous treatment for leishmaniasis with Sb, pentamidine, amphotericin B, miltefosine, imidazoles, allopurinol in the last 3 months.
* Other diseases that would be likely in the PI's opinion to interact, either positively or negatively, with treatment.

Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No